Class II · Moderate risk Terminated
Bisacodyl Suppositories
Reason CGMP Deviations: products were stored outside the drug label specifications.
Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder
What was recalled
Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02
- Recalling firm
- Braintree Laboratories Inc.
- NDC code
- 52268-523-02
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-911-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Bisacodyl recalls
See all
Class II · Moderate risk Ongoing
Qp Laxative Bisacodyl 5 Mg Tablet 50 Ct Sku 902449 Qp Women…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Terminated
Bisacodyl Suppositories
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Laxative Suppositories
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Biscolax Laxative
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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